Device for suture attachment for minimally invasive heart valve repair

ABSTRACT

Disclosed herein are minimally invasive systems and methods for intravascularly accessing the heart and performing a transcatheter repair of a heart valve by inserting a suture as an artificial chordae into a heart valve leaflet. In various embodiments, such systems and methods can be employed in other heart valve repair procedures such an edge to edge repair to coapt leaflets by inserting one or more sutures that retain the leaflets in a coapted positioned or inserting a suture to repair a tear in a leaflet, for example.

RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.62/728,349 filed Sep. 7, 2018, which is hereby fully incorporated hereinby reference.

TECHNICAL FIELD

The disclosed invention relates to minimally invasive delivery of asuture. More particularly, the disclosed invention relates to attachingthe suture as an artificial chordae tendineae to a flailing orprolapsing leaflet in a beating heart.

BACKGROUND

The mitral and tricuspid valves inside the human heart include anorifice (annulus), two (for the mitral) or three (for the tricuspid)leaflets and a subvalvular apparatus. The subvalvular apparatus includesmultiple chordae tendineae, which connect the mobile valve leaflets tomuscular structures (papillary muscles) inside the ventricles. Ruptureor elongation of the chordae tendineae results in partial or generalizedleaflet prolapse, which causes mitral (or tricuspid) valveregurgitation. A commonly used technique to surgically correct mitralvalve regurgitation is the implantation of artificial chordae (usually4-0 or 5-0 Gore-Tex sutures) between the prolapsing segment of the valveand the papillary muscle.

This procedure was traditionally an open heart operation generallycarried out through a median sternotomy and requiring cardiopulmonarybypass with aortic cross-clamp and cardioplegic arrest of the heart.Using such open heart techniques, the large opening provided by a mediansternotomy or right thoracotomy enables the surgeon to see the mitralvalve directly through the left atriotomy, and to position his or herhands within the thoracic cavity in close proximity to the exterior ofthe heart for manipulation of surgical instruments, removal of excisedtissue, and/or introduction of an artificial chordae through theatriotomy for attachment within the heart. However, these invasive openheart procedures produce a high degree of trauma, a significant risk ofcomplications, an extended hospital stay, and a painful recovery periodfor the patient. Moreover, while heart valve surgery produces beneficialresults for many patients, numerous others who might benefit from suchsurgery are unable or unwilling to undergo the trauma and risks of suchopen heart techniques.

Techniques for minimally invasive thoracoscopic repair of heart valveswhile the heart is still beating have also been developed. U.S. Pat. No.8,465,500 to Speziali, which is incorporated by reference herein,discloses a thoracoscopic heart valve repair method and apparatus.Instead of requiring open heart surgery on a stopped heart, thethoracoscopic heart valve repair methods and apparatus taught bySpeziali utilize fiber optic technology in conjunction withtransesophageal echocardiography (TEE) as a visualization techniqueduring a minimally invasive surgical procedure that can be utilized on abeating heart. More recent versions of these techniques are disclosed inU.S. Pat. Nos. 8,758,393 and 9,192,374 to Zentgraf, which disclose anintegrated device that can enter the heart chamber, navigate to theleaflet, capture the leaflet, confirm proper capture, and deliver asuture as part of a mitral valve regurgitation (MR) repair. Theseminimally invasive repairs are generally performed through a small,between the ribs access point, followed by a puncture into the ventriclethrough the apex of the heart. Although far less invasive and risky forthe patient than an open heart procedure, these thoracoscopic proceduresare still involving significant recovery time and pain.

It would be advantageous for a minimally invasive suture delivery systemto be able to suture valve leaflets in a beating heart procedure withoutrequiring an open surgical approach or an incision into the exteriorventricular wall of a minimally invasive thoracoscopic approach in orderto minimize blood loss and reduce recovery time and pain. For example,various approaches to heart valve repair using intravascular access havebeen proposed, including U.S. Patent Publication Nos. 2007/0118151 and2013/0035757 and U.S. Pat. Nos. 7,635,386, 8,043,368 and 8,545,551.These approaches, however, have not resolved various issues with respectto a successful intravascular technique that could match the results ofopen heart or thorascopic techniques, including the known challenges ofeffectively grasping and retaining the beating leaflets during a beatingheart intravascular procedure.

SUMMARY

Disclosed herein are minimally invasive systems and methods forintravascularly accessing the heart and performing a transcatheterrepair of a heart valve by inserting a suture as an artificial chordaeinto a heart valve leaflet. In various embodiments, such systems andmethods can be employed in other heart valve repair procedures such anedge to edge repair to coapt leaflets by inserting one or more suturesthat retain the leaflets in a coapted positioned or inserting a sutureto repair a tear in a leaflet, for example.

In an embodiment, a suture attachment catheter configured to repair aheart valve by inserting a suture in a valve leaflet of a beating heartof a patient can include a generally flexible catheter body, a sutureattachment assembly, and a control handle. The suture attachmentassembly can include a proximal clamping jaw, a rail selectivelyslideable with respect to the proximal clamping jaw and a distalclamping jaw hingedly attached to the distal end of the rail. Thecontrol handle can include a rail actuator configured to selectivelylongitudinally slide the rail with respect to the proximal clamping jawand a jaw actuator configured to selectively pivot the distal clampingjaw between a first position for delivery of the suture attachmentassembly into the heart and a second position for capturing a valveleaflet between the proximal clamping jaw and the distal clamping jaw.In embodiments, a flexible member extends from the jaw actuator throughthe catheter body to a distal surface of the distal clamping jaw and isselectively moved to pivot the distal clamping jaw.

Various embodiments of systems, devices and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the present invention. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, implantation locations, etc. have been described for use withdisclosed embodiments, others besides those disclosed may be utilizedwithout exceeding the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIGS. 1A-1C depict a distal end of a suture attachment device accordingto an embodiment.

FIGS. 2A-2B depict a distal jaw of the suture attachment device of FIGS.1A-1C.

FIG. 3 depicts a proximal clamping jaw of the suture attachment deviceof FIGS. 1A-1C.

FIGS. 4A-4B depict schematic representations of the routing of one ormore sutures through a suture attachment device according to anembodiment.

FIG. 5A-5D depict a sequence of steps for inserting one or more suturesinto a valve leaflet according to an embodiment.

FIG. 6 depicts a flowchart of method steps for inserting one or moresutures into a valve leaflet according to an embodiment.

FIG. 7 depicts a distal end of a suture attachment device according toan embodiment.

FIGS. 8A-8D depict a distal end of a suture attachment device accordingto an embodiment.

FIGS. 9A-9B depict a distal end of a suture attachment device accordingto an embodiment.

FIGS. 10A-10D depict a distal end of a suture attachment deviceaccording to an embodiment.

FIGS. 11A-11C depict a distal end of a suture attachment deviceaccording to an embodiment.

FIGS. 12A-12F depict a handle end of a suture attachment deviceaccording to an embodiment.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

The present application describes various devices and methods that canbe employed on the beating heart of a patient in a minimally invasivemanner to treat mitral valve regurgitation as described above.Embodiments as described herein can be used to restrain a prolapsingleaflet to prevent leaflet prolapse and to promote leaflet coaptation.In other embodiments, such systems and methods can be employed in otherheart valve repair procedures such an edge to edge repair to coaptleaflets by inserting one or more sutures that retain the leaflets in acoapted positioned or inserting a suture to repair a tear in a leaflet,for example.

FIGS. 1A-1C depict a distal end 102 of a suture attachment device 100according to an embodiment. Suture attachment device 100 can beconfigured as leaflet attachment catheter with the distal end 102 beingthe distal capture portion of the leaflet attachment catheter. Inembodiments, the catheter is configured to enter the patient through adelivery sheath which is inserted at the groin, extends through theinferior vena cava to the right atrium and then through a transeptalpuncture into the left atrium. The catheter has a shaft or body 104 of alength to extend through the delivery sheath while allowing the distalend 102 to extend distal to the distal end of the delivery sheath withinthe patient while also extending proximally to the proximal end of thedelivery sheath at the proximal end of the catheter allowing thephysician to access the control handle attached to the proximal end ofthe catheter. In such an embodiment, the catheter body 104 can beflexible.

In embodiments, the total working length of the catheter body can bebetween about 130 cm and 140 cm. On a typical patient, this lengthenables the catheter to be advanced into the heart from the groin withadditional length for the delivery system catheters and control handles.The catheter can be flexible and configured to be able to flex around acurve having a diameter between 0.75 inches and 1.5 inches, such as, forexample, a 0.9 inch diameter curve, depending on the septal puncturelocation and the specific anatomy of the patient. In other embodiments,the total working length can be between about 100 cm and 170 cm in orderto accommodate very short or very tall patients.

In embodiments, the working length of the distal end 102 of the deviceadvanced out of the delivery system can be between about 3 cm and 6 cm.The distal end 102 can be generally rigid, but provided with someflexibility as the device is advanced through the delivery system by ahinged distal jaw as will be described herein. This flexibility enablesthe distal end to traverse curves on the range of 0.75 inches to 1.5inches within the internal diameter of the delivery system which, insome embodiments, may be approximately 5-6 mm.

In embodiments, catheter shaft or body is comprised of a combination ofstainless steel braid and coil reinforced nylon or polyurethane toprovide axial and torsional rigidity along with flexibility. Thecomponents of the distal end, such as the clamping jaws as will bedescribed herein, can be comprised of, for example, medical gradepolymers or machined stainless steel.

The distal end 102 of the catheter 100 includes a distal jaw 106 and aproximal jaw 108 and mechanisms that actuate the jaws between theirrespective positions depending on the portion of the procedure beingdone, as will be described herein. Distal jaw 106 is hingedly attachedto a rail 110. Proximal jaw 108 is selectively slideable along rail 110and can include a loop 109 configured as a wire extending upwardlytherefrom. In embodiments, wire loop 109 can be formed from a shapememory material such as, e.g., nitinol. In operation, distal jaw 106 canselectively be actuated between a first position shown in FIG. 1A and asecond position shown in FIGS. 1B-1C. Proximal jaw 108 can selectivelyslide along rail 110 between a first, proximal position depicted inFIGS. 1A-1B and second, distal position depicted in FIG. 1C. In anotherembodiment, the proximal jaw 108 can be fixed in its axial movement andthe rail 110 with the distal jaw 106 attached can slide distally from afirst position with respect to the fixed proximal jaw to a secondposition to effectively increase the distance between the proximal jawand the distal jaw.

Referring now also to FIG. 2A-2B, further details regarding the distaljaw 106 according to an embodiment will be described. Distal jaw 106includes a leaflet clamping surface having a plurality of stepped ridges112 configured to enhance the ability of the jaws to clamp and retain avalve leaflet. Distal jaw 106 further includes a rail opening 114 and apair of aligned apertures 116 extending through distal jaw 106. Railopening 114 is configured to receive a distal end of rail 110 (see FIG.1A) with the apertures 116 configured to receive a pin, rod, etc. thatextends through a corresponding aperture in rail 110 to form the hingedattachment between distal jaw 106 and rail 110. Distal jaw 106 furtherincludes a pair of clamping face openings 118. A portion of clampingface openings 118 extends completely through the distal jaw 106 whereasanother portion extends only partway through due to the presence ofledges 120. A distal post 122 extends upwardly from and a distalaperture 124 extends through each ledge 120. Clamping face openings 118further each define a pair of intermediate tabs 126. A recessed opening130 also extends through a ledge 128 extending between the openings 118.

Referring now to FIG. 3, further details regarding an embodiment of aproximal clamping jaw 108 are depicted. Proximal jaw 108 includes a railopening 132 that conforms to a shape of the rail 110 (see FIG. 1A) toenable proximal jaw 108 to selectively slide along rail 110. Proximaljaw 108 further includes a distal clamping face 134 having a pair ofelongate slots 136 therethrough. Elongate slots 136 each define both asuture slot 138 and a needle hole 140. An actuator aperture 142 isfurther defined through proximal jaw 108.

As noted above, and with reference again to FIGS. 1A-1C, distal jaw 106can be actuated between at least two positions. The first, deliveryposition is depicted in FIG. 1A and includes the distal jaw 106 beingpositioned at an obtuse angle (i.e., an angle between 90 and 180degrees) relative to the rail 110. In the depicted embodiment, thedistal jaw 106 is positioned approximately 120 degrees relative to therail. The delivery position is the configuration in which the distal end102 is delivered through the delivery system to the point of use (i.e.,adjacent a valve leaflet). The second, clamping position is depicted inFIGS. 1B-1C and includes the distal jaw 106 positioned at a right angleor acute angle (less than 90 degrees) relative to the rail 110. In thedepicted embodiment, the distal jaw 106 has been actuated approximately90 degrees relative to the first position, such that the jaw 106 ispositioned at an approximately 60 degree angle relative to the rail 110.The clamping position is the position the distal jaw 106 is moved towhen the jaw 106 has been positioned inferior to a leaflet to enable tojaw surface to contact and stabilize the leaflet for capture of theleaflet.

Actuation of the distal jaw 106 between the delivery position and theclamping position is accomplished with a flexible member 144. Inembodiments, flexible member 144 can be a nitinol wire. Flexible member144 can extend through a lumen 146 through the catheter shaft or body104 and the rail 110 and exits lumen 146 at a distal face of the rail110. The distal end of the flexible member 144 attaches to the distaljaw 106. Although not depicted as such in FIGS. 1B-1C, in embodimentsthe flexible member 144 can be attached to the distal jaw 106 via one ormore of distal apertures 124. When this flexible member 144 is furtherextended from the lumen 146, its connection to the distal jaw 106 movesthe jaw from the first, delivery position in which it is delivered tothe second, clamping position in which is able to contact the inferiorsurface of the valve leaflet. The distal jaw 106 can be moved back tothe delivery position by pulling on the flexible member 144. Flexiblemember 144 can be controlled with sliding movement of an actuatordisposed at a proximal end of the device.

The proximal jaw 108 is actuated with a flexible proximal jaw actuatorrod 148, as shown in FIG. 1C, that connects to the actuator aperture 142of the proximal jaw 108. The actuator rod 148 can be pushed moved anactuator control at the proximal end of the device to advance theproximal jaw 108 along the rail 110 to close the distance between theproximal jaw 108 and the distal jaw 106 to clamp a leaflet therebetween.Wire loop 109 on proximal jaw 108 is configured to approximately mate(on opposite sides of the leaflet) with the distal jaw 106 when bothjaws have been actuated to the clamping position. When the proximal jaw108 is advanced to the actuated distal jaw 106 with the valve leafletbetween them, it will provide pressure to stabilize the leaflet betweenthe jaws while minimizing potential damage to the leaflet. In someembodiments, distal clamping face of proximal jaw 108 can be angled tomatch the angle of distal jaw 106 in the clamping position (i.e.,approximately 60 degrees in the depicted embodiment).

The above-described jaw configuration provides a number of advantages.One advantage is that it allows for relatively large surface areas to beincluded in the clamping portion of the jaw by providing for a firstconfiguration in which the larger distal jaw can more easily bedelivered and a second, different configuration in which the larger jawis employed to capture and retain a leaflet. Another advantage is thatthe hinged connection reduces the rigid length of the device while stillallowing a large jaw opening distance. It does this by allowing thehinged distal jaw to flex as needed while the system is advanced throughthe small radius that is required for delivery to the mitral valvethrough the vasculature and a septal puncture.

FIGS. 4A-4B depict schematic representations of an embodiment of amanner in which one or more sutures can be routed through the device100. FIG. 4B depicts device without the proximal jaw 108 and distal jaw106 as well as a single suture 10 for sake of clarity. FIG. 4A depicts apair of sutures 10 carried side by side in device 100. Because eachsuture is routed through device in an identical but side by side manner,only the routing of a single suture 10 will be described in detail. Inembodiments, one or more sutures can be preinstalled in the catheterprior to delivery to the end user (i.e., surgeon).

Suture 10 can be configured in a continuous loop through device 100. Therouting of the suture 10 through the distal jaw is done by securing afirst distal end suture loop 12 portion around the distal post 122 onthe leaflet clamping surface side of the distal jaw 106. The suture 10then extends from both sides of the post and around the opposite side ofthe intermediate tabs 126 in the distal clamping jaw 106, through thesuture slots 138 in the proximal jaw 108 and then into a suture channelextending through the catheter body 104. Within each suture channel ofthe catheter body 104, both legs of the suture 10 are doubled with theresulting proximal double loop 14 of suture 10 being held with aseparate looped suture 20 which is connected within the proximal controlhandle 150 by a spring 22 to keep tension on the suture 10 to keep it inplace in the catheter body 104. The second, proximal end suture loop 16extends from the doubling point 14 distally until it is looped around aneedle support tube 152 through which the needle is advanced topenetrate the leaflet and insert the suture around the leaflet.

The proximal control mechanism 150 for the device 100, depictedschematically in FIG. 4B, consists of a main body that allowscomfortable access to the controls of the device. The separate loopedsuture 20 is secured in the handle 150 by a spring 22 at one end of theloop 20, and a disengagable connection 24 at the other. As shown in FIG.5A, the needle 154 extends through the control mechanism 150 and theproximal end of the needle contains a handle 156 which allows forcomfortable access and control of the needle 154. The control handlealso houses two sliding controls (not depicted). The first slidingcontrol is connected to the distal jaw actuator such as flexible member144 extending through a lumen in the catheter body 104. Distal relativemovement of the first slider with respect to the control handle 150 willactuate the distal jaw 108. The second sliding control is connected by aflexible rod 148 extending through the catheter body 104 to the proximaljaw 108. Distal relative movement of the second slider with respect tothe control handle 150 will actuate the proximal jaw 108. Furtherdetails regarding proximal controls for control elements at a distal endof a leaflet capture catheter can be found in U.S. Provisional PatentApplication No. 62/647,162, filed Mar. 23, 2018, which is herebyincorporated by reference herein.

In some embodiments, one or more channels through the device couldalternatively accommodate or could additionally be added to incorporatefiber optic capture confirmation elements. In such an embodiment, one ormore pairs of transmission and return fibers run through the device toenable the capture confirmation system to provide a binary indication ofwhether the valve leaflet is grasped between the clamping jaws bydisplaying a first color when a surface of the valve leaflet confrontsthe fiber optic pairs and a second color (e.g., of blood) when the valveleaflet does not confront the fiber optic pairs at the interiorsurfaces. Further detail regarding fiber optic capture confirmation of avalve leaflet in a beating heart of a patient can be found in U.S. Pat.Nos. 8,465,500 and 8,758,393 and U.S. patent application Ser. No.16/363,701, previously incorporated herein by reference.

FIGS. 5A-5D depict a sequence of steps of an embodiment of using device100 to insert one or more sutures into a valve leaflet and FIG. 6depicts a flowchart of method steps 200 corresponding to the sequence.FIGS. 5A-5D depict the device 100 without the distal jaw 106 andproximal jaw 108 for sake of clarity. In step 202, the device isinserted through the delivery system with the distal jaw in theun-actuated, first delivery configuration. In embodiments, access intothe heart adjacent the mitral valve can be gained intravascularly asdescribed herein. Further details regarding such access can be found inU.S. Provisional Patent Application No. 62/647,162 incorporated byreference above. In embodiments, the device is inserted with two sutures10 loaded into the device, though only a single suture 10 is depicted inFIGS. 5A-5D for sake of clarity.

After exiting the delivery system, the distal jaw of the device isadvanced below the level of the mitral valve at step 204 and the distaljaw is actuated at step 206 moving the jaw to an angle in which it willcontact the valve leaflet. After the device is positioned to the desiredpoint of leaflet attachment, the system is moved superiorly at step 208with respect to the valve until the lower (distal) jaw contacts theinferior side of the valve leaflet. The proximal jaw is then actuated atstep 210 by sliding it along the rail until the leaflet is clamped andstabilized between the jaws.

Once the leaflet 30 is stabilized between the jaws, the needle 154 isadvanced at step 212 puncturing the valve leaflet and extended throughan opening in the distal jaw and between the suture segments that arepositioned around the post and intermediate tabs in the distal jaw. Theneedle 154 is then retracted which engages the suture with the hook inthe needle profile as shown in FIG. 5A at step 214. This pulls thedistal suture loop 12 off from the distal post of the distal jaw and theneedle can then pull the suture loop through the puncture in the valveleaflet 30 at step 216 as depicted in FIG. 5B. Due to the angle geometryof the intermediate tabs 126, a distal portion of the suture will remainwrapped around them keeping this distal portion of the suture fromcontacting the distal side of the leaflet. This enables the suture to betightened without putting force on the leaflet that could potentiallydamage the leaflet. With the needle 154 on the proximal side of thevalve leaflet 30 and the distal suture loop 12 in the needle hook, thedisengagable connection 24 to the proximal suture loop 16 via theseparate suture 20 looped around the double loop 14 is released in thecontrol handle at step 218. Further retraction of the needle 154 at step220 will then pull the proximal loop 16 distally into the system. At thepoint that the needle 154 is fully pulled from the system with thedistal suture loop 12 that is in the needle 154 exposed, the resultinggirth hitch knot 26 is very close to being tightened at the distal endof the system as depicted in FIG. 5C. The final step 222 to tighten theknot 26 is when the secured distal loop 12 is pulled distally from theneedle tube allowing the knot 26 to be secured at the leaflet asdepicted in FIG. 5D.

Once the knot 26 is tightened on the leaflet 30, the delivery system canbe retracted at step 224. To do so, the proximal jaw may be released andmoved proximally, un-clamping the valve leaflet. The distal jaw is thenun-actuated. The change in the distal jaw angle releases the suture fromintermediate tabs 126 in the distal jaw which then fully detaches thesystem from the leaflet. The catheter can then be retracted into thedelivery system or the optional second suture may be delivered by movingthe system to a different position along the leaflet and repeating theprocess sequence described above.

Once one or more sutures have been attached to the leaflet, thesuture(s) can be adjusted to provide an appropriate length and/ortension for proper valve function and anchored. Further detailsregarding tensioning and anchoring of sutures can be found in U.S.patent application Ser. Nos. 16/406,736; 16/406,764; and 16/406,799,each of which is hereby incorporated by reference herein.

FIG. 7 depicts another distal end of a leaflet capture catheter 302according to an embodiment. In this embodiment, the proximal jaw 308 isstationary and longitudinally fixed in place. Rail 310 can be slidableto adjust the distance between proximal jaw 308 and distal jaw 306 toaid in leaflet capture as will be discussed in more detail below withregard to FIGS. 8A-8D. As with leaflet capture catheter 102, the distaljaw 306 can be pivotable to also aid in leaflet capture. Each needle 322can include a keying wire 323 that retains the needle in place distallyof the needle lumens 325. In one embodiment, keying wire 323 can beprovided with a forward bias and the needle 322 a backward bias to keepthe needle in place and when the needle 322 is pushed forward the wire323 drops out of the path of the needle 322. In another embodiment, thekeying wire 323 can be retracted, such as with a control element on theproximal handle of the device attached to the wire, such that no springbiases are utilized. This embodiment depicts two sets of fiber opticcables 359 (each including one transmission fiber and one return fiber)disposed in fiber optic channels at the distal clamping face 334 of theproximal jaw 108 to aid in verifying proper leaflet capture. Thedepicted embodiment further includes a stabilizing loop 314 as describedin more detail below. Leaflet capture catheter 302 can further includeany feature described with respect to the other embodiments disclosedherein.

FIGS. 8A-8D depict another distal end of a leaflet capture catheter 402according to an embodiment. This embodiment can be configured to carryonly a single suture and a single needle 454 and can have a single pairof fiber optics 459 in a fiber optic channel 457. Distal jaw 406 can behingedly attached to rail 410. Rail 410 can be slideable with respect toproximal jaw 408 to adjust a separation distance between the jaws 408,410. Referring to FIGS. 8C-8D, rail 410 can have limited length and beconnected to a hypotube (not pictured) controllable from the proximalhandle to slide rail 410 within a rail channel 409 defined in proximalclamping jaw 408. Proximal jaw 408 can further including a locking tab411 that can mechanically interact with a locking feature on rail 410 toprevent the rail 410 from being completed moved distally from the railchannel 409. In embodiments, the rail 410 can be biased proximally,towards a closed position with a spring force that is overcome to openthe jaws, which enables the jaws to remain clamped around a leaflet oncea leaflet is captured. Referring to FIG. 8A, the needle channel 415along proximal jaw 408 across which the needle 454 travels to engage theleaflet can be ramped at an upwards angle to ensure the leaflet ispierced sufficiently above the leaflet edge. Leaflet capture catheter402 can further include any feature described with respect to the otherembodiments disclosed herein.

FIGS. 9A and 9B depict alternatives as to how a suture can be routed tothe distal capture jaw of any of the leaflet capture catheters disclosedherein including, for exemplary purposes, leaflet capture catheter 402.Referring to FIG. 9A, in this embodiment the suture 10 extends from alumen 438 in the proximal clamping jaw 408, with each strand 11 of thesuture extending around a channel 473 one either side of the proximalclamping jaw 408. The strands then extend up and form a loop at thedistal clamping jaw for retrieval by the needle 454. The suture 10extends back to the proximal handle control where it can be maintainedunder an appropriate tension for retrieval by the needle. In thisembodiment, the suture lumen 438 is positioned above the needle 454 suchthat the suture 10 emerges from the proximal clamping jaw 408 from abovethe needle 454. Referring now to FIG. 9B, in this embodiment the suture10 extends from a lumen 438 in a lower part of the proximal clamping jaw408 below the needle 454 and wraps around the needle tube 452 containingthe needle 454. Both suture ends 11 then extend along the same channel473 on a single side of the proximal clamping jaw 408 and to the distalclamping jaw 406. The suture 10 also can then extend back to theproximal handle control. For suture capture by the needle 454, thesuture 10 is released from the needle tube 452 by an actuation means,such as a control mechanism that attaches to and withdraws the tube or awire that holds the suture on the tube and is then retracted, forexample. In each of these embodiments, the suture 10 can be held in theproximal jaw by a variety of means including, for example, with featuressuch as the distal posts 122 and intermediate tabs 126 described above.

Both of the embodiments of FIGS. 9A-9B greatly simply the suture routingand tensioning aspects of the device with respect to, for example, FIG.4B. The suture 10 in these embodiments is no longer folded in half andcan extend back to the handle, eliminating the need for the separatelooped suture 20 and disengageable connection 24 as well as, in theembodiment of FIG. 9A, the proximal end suture loop 16 around the needletube 152.

FIGS. 10A-10D depict another distal end of a leaflet capture catheter502 according to an embodiment. Leaflet capture catheter 502 issubstantially similar to the leaflet capture catheter 402 described withregard to FIGS. 8A-8D, and any features of either leaflet capturecatheter could be utilized with the other. Leaflet capture catheter 502can further include any features described with respect to the otherembodiments disclosed herein. As with previous embodiments, catheter 502includes a proximal clamping jaw 508 and a distal clamping jaw 506having an adjustable separation distance via rail 510.

Distal jaw 506 can be hingedly attached to rail 510 with hinge pin 516and can be actuated from the open, delivery position (depicted in FIG.10A) to the closed, clamping position (depicted in FIG. 10B) with aflexible member 544 such as that depicted in FIGS. 11A-11C and describedabove with respect to catheter 102. For the closed position, the distaljaw 506 can be pivoted to an angle with respect to the rail thatgenerally matches an angle of the proximal jaw 508 as depicted in FIG.10B. Distal jaw 506 can include a wire housing 545 having a slot intowhich the flexible member 544 is inserted and configured to retain theflexible member 544 therein. As will be shown in more detail below,flexible member 544 is routed through the distal jaw 506 and into thewire retainer 545 in such a manner that it is retained in place withoutany glue or welding required. The distal jaw 506 can be configured tostop pivoting at the depicted capture angle due to the bottom of the jawabutting the rail, which prevents the jaw from being pivoted too far.Distal jaw 506 can further include suture retention features, includingsuture routing post 522, distal suture routing fins 526 and suturerouting lumens 518, which will also be discussed in more detail below.Leaflet grasping teeth 512 can be disposed around a perimeter of distaljaw 506 to aid in retaining a clasped leaflet.

Proximal jaw 508 can similarly include ridged or stepped surfaces 513that function as leaflet grasping teeth to aid in retaining a leafletbetween jaws 506, 508. An optics housing 557 can be disposed in proximaljaw 508 to contain fiber optics for confirming leaflet capture. Proximalsuture routing fins 573 can be disposed on both sides of proximal jaw508 to aid in guiding and retaining suture, as described in more detailbelow. As with previous embodiments, a wire loop 509 can be provided toaid in suture capture and retention by pivoting upwards after theleaflet capture catheter 502 exits the delivery catheter to increase thesurface area of the proximal jaw 508 for leaflet capture. The expandedconfiguration is depicted in FIGS. 10A-10B, in which the wire loop haspivoted up above the proximal jaw. Proximal jaw 508 can be provided withloop cutouts 507 along the sides of jaw to allow the wire loop 509 to beretained along the sides of catheter 502 when in the compressedconfiguration without increasing the French size of the device.

Rail 510 is slidably extendable from a slot 532 in proximal jaw 508 toadjust the distance of distal jaw 506 from proximal jaw 508. A railslide hypotube 548 that extends back to a device handle can be insertedinto a slide lumen 547 in rail and fixed to rail by, e.g., soldering, toenable control of movement of rail 510 and distal jaw 506 from thehandle. As will be discussed in more detail below, flexible member 144can extend through slide hypotube 548 between the handle and the wirehousing 545 in the distal jaw 506 to enable pivoting control of thedistal jaw 506 via flexible member 144 from the handle. Rail 510 canfurther include rail slide fins 511 that extend outwardly from a body ofrail 510. Rail slide fins 511 extend the full with of the slot 532 tolimit the rail 510 to longitudinal or axial movement. Fins 511 areprovided with stop features or projections 560 on the proximal end offins that prevent the rail 510 from being extended completely out of thedistal end of the slot 532 of the proximal jaw 508.

Leaflet capture catheter 502 can further include a jaw attachmenthypotube 550 disposed between the catheter body of the device and theproximal jaw component 508. Jaw attachment hypotube 550 can be aseparate hypotube that is, e.g., laser cut, and then reflowed onto thecatheter body and laser welded to the proximal jaw to connect theleaflet capture end of the device to the catheter body. Jaw attachmenthypotube 550 can further include a proximal rail stop 551 that preventsthe rail 510 from moving proximally to a position that would move thedistal jaw 506 too close to the proximal jaw 508.

Referring now to FIGS. 11A-11C, leaflet capture catheter 502 isschematically depicted with a flexible member 544 and a suture 10 routedtherethrough. Flexible member 544 extends through and out of rail slidehypotube 548 in rail 510 and then extends around distal jaw 506 and intowire housing 545. Suture 10 can be configured as a closed loop having apair of suture ends that extend out of a common opening in the face ofproximal jaw 508, along proximal suture routing fins 573, underneath thedistal portion of proximal jaw 508 and then along each side of the rail510 towards the distal jaw 506. Each suture end 11 then extends throughone of the suture routing lumens 518 in the distal jaw 506, beneath oneof the suture routing fins 526, and one end of the suture loop 12 iswrapped around suture routing post 522 under tension for retrieval byneedle. Suture routing lumens 518 keep the suture mounted on the distaljaw while the needle is retrieving the suture. When the needle graspsthe suture, it pulls the suture off of the suture routing post 522 andback through the leaflet. Suture routing fins 526 keep the suture fixedin the jaw until the suture is completely retrieved by the needle. Oncethe suture is retrieved, the distal jaw is opened, which releases boththe leaflet and the suture from the distal jaw. The suture loop can beformed by tying a knot with the two suture ends. In embodiments, a bloodknot can be tied, reinforced with adhesive, and then crimped to reducethe profile. Further details for suture routing and tensioning(generally in the context of a transapical procedure) can be found inU.S. Pat. No. 8,758,393 andhttps://neochord.com/wpcontent/uploads/2019/02/700010-002_Rev_5_IFU_pc_eng.pdf.

FIGS. 12A-12F depict a handle 600 for controlling a leaflet capturecatheter, such as, for example, leaflet capture catheter 502, accordingto an embodiment. Although handle 600 will be specifically described forexemplary purposes with regard to control of leaflet capture catheter502 depicted in FIGS. 10A-10D and 11A-11C, it should be understood thathandle 600 could be utilized and/or adapted for use with other leafletcapture catheters, including the other leaflet capture cathetersdescribed and depicted herein.

Handle 600 includes a handle body 602 that houses and/or connects to anumber of components for controlling leaflet capture catheter andperforming a mitral valve repair procedure. A hemostatis hub 604 can bedisposed within housing. Hemostatis hub can be a valved structure thatprevents blood from leaking back from the catheter into the handle andcan also enable air to be flushed from the system through a flush port606 that connects to hemostasis hub 604 through housing 602 via tubing608. Flush port 606 can further enable the device to be flushed withsaline to clean out the catheter. A strain relief knob 610 comprised ofa flexible material can be disposed at a distal end of handle 600 withcatheter body extending therethrough to aid in preventing the catheterbody from kinking during the procedure. A suture tensioning assembly 612can also be disposed within housing 602 to maintain the suture under thetension that keeps the suture positioned at the distal end of the deviceas described above until captured by the needle. In an embodiment,suture tensioning assembly 612 can include a tensioned spring 613 withan attached o-ring 615 to releasably hold the suture under tension.

Handle 600 further includes a number of control elements that enable anoperator to control elements at the distal end of leaflet capturecatheter 502 from the proximal portion of the device externally of thebody. A rail slide actuation member 614 can be disposed in the housingand connected to the rail slide hypotube 548 such that forward movementof the rail slide actuation member 614 causes the rail slide 510 anddistal jaw 506 to move forward and increase a distance between thedistal jaw 506 and the proximal jaw 508. In embodiments, a spring orother resilient element (not pictured) contained in housing can bias therail slide actuation member 614 and distal jaw 506 to the proximal,closed position. A flexible member actuation nut 616 can be disposed inthe housing 602 and affixed to the flexible member 544 such thatrotation (e.g., clockwise) of the actuation nut 616 moves the flexiblemember 544 forward to pivot the distal jaw 506 to the closed position.Reverse rotational movement of the actuation nut 616 (e.g.,counter-clockwise) can therefore pull the flexible member 544 back topivot the distal jaw 506 back to the open position. A control knob 618can extend distally of the housing 602 for control of both the railslide actuation member 614 and the flexible member actuation nut 616.Control knob 618 can be functionally linked to rail slide actuationmember 614 and flexible member actuation nut 616 such that pushing orpulling control knob 618 moves the rail slide actuation member 614 (anddistal jaw 506) distally and proximally and rotation of control knob 618moves the flexible member 544 (thereby opening or closing the distal jaw506) such that both functions can be controlled with a single controlelement. Control knob 618 can include a threaded portion 617 along whichactuation nut 616 can travel when control knob 618 is rotated. A slot619 can be disposed on housing in order to provide an operator withvisual confirmation that the distal jaw is opened or closed based on theposition of actuation nut 616.

Handle 600 can further be used to control the needle for puncturing theleaflet and retrieving the suture back through the leaflet. A needlerelease assembly 620 can include a needle grip 622 and a release handle624 biased apart by a resilient element such as a spring 626. Needlerelease assembly 620 can be functionally connected to the needle suchthat the needle is prevented from moving forward out of the proximal jaw608 until the user compresses the needle grip 622 and release handle 624to overcome the bias of the spring 626. A needle window 623 can beprovided through housing 602 to enable on operator to visually confirmneedle deployment. A suture release pin 628 can be disposed within thehousing 602 and controlled with a release lever 630 on the housing.Actuation of the release lever 630 removes the suture release pin 628 tofree the suture for retrieval and enable remove of the needle handleassembly 620 to retrieve the needle with the suture. In embodiments, therelease lever 630 rests on a ledge that prohibits the lever 630 frommoving down to release the suture release pin 628 such that the levermust be slid horizontally in order to be moved down in order to preventaccidental release. A needle window 623 can be provided through housing602 to enable on operator to visually confirm needle deployment prior toreleasing the suture.

FIG. 12B depicts the routing of a suture 10 through the handle 600according to an embodiment. The suture loop 12 exits through thehemostatis hub 604 and wraps around the o-ring 615 attached to thetensioning spring 613 of the suture tensioning assembly 612. The end ofthe suture loop 12 is placed over the suture release pin 628 to enablethe suture to be retrieved from the distal jaw 506 upon actuation of therelease button 620.

Although specifically described with respect to the mitral valve, itshould be understood the devices described herein could be used to treatany other malfunctioning valve, such as the tricuspid and aortic valves.Further, although it should be understood that the devices described inthe present application could be implanted into the beating heart of thepatient via various access approaches known in the art, includingtransapical approaches (e.g., through the apex of the left ventricle)and transvascular approaches, such as transfemorally (through thefemoral vein). One example of a transapical access approach that couldbe employed is described in U.S. Pat. No. 9,044,221, previouslyincorporated by reference herein. One example of a transvascular accessapproach that could be employed is described in U.S. Patent PublicationNo. 2013/0035757, which is hereby incorporated by reference herein. Thisversatility in access approach enables the access site for the procedureto be tailored to the needs of the patient.

Various embodiments of systems, devices, and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the present invention. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, implantation locations, etc. have been described for use withdisclosed embodiments, others besides those disclosed may be utilizedwithout exceeding the scope of the invention.

Persons of ordinary skill in the relevant arts will recognize that thesubject matter hereof may comprise fewer features than illustrated inany individual embodiment described above. The embodiments describedherein are not meant to be an exhaustive presentation of the ways inwhich the various features of the subject matter hereof may be combined.Accordingly, the embodiments are not mutually exclusive combinations offeatures; rather, the various embodiments can comprise a combination ofdifferent individual features selected from different individualembodiments, as understood by persons of ordinary skill in the art.Moreover, elements described with respect to one embodiment can beimplemented in other embodiments even when not described in suchembodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specificcombination with one or more other claims, other embodiments can alsoinclude a combination of the dependent claim with the subject matter ofeach other dependent claim or a combination of one or more features withother dependent or independent claims. Such combinations are proposedherein unless it is stated that a specific combination is not intended.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of 35 U.S.C. § 112(f) are not to be invoked unless thespecific terms “means for” or “step for” are recited in a claim.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

The invention claimed is:
 1. A suture attachment catheter configured torepair a heart valve by inserting a suture in a valve leaflet of abeating heart of a patient, comprising: a generally flexible catheterbody having a proximal end, a distal end and a length greater than 100cm; a suture attachment assembly proximate the distal end of thecatheter body, the suture attachment assembly including: a proximalclamping jaw disposed adjacent the distal end of the catheter body; arail having a proximal portion and distal portion, the proximal portionconfigured to be selectively longitudinally slideable with respect tothe proximal clamping jaw; and a distal clamping jaw hingedly attachedto the distal portion of the rail; a control handle operable attached tothe proximal end of the catheter body, the control handle including: arail actuator configured to selectively longitudinally slide the railwith respect to the proximal clamping jaw; and a jaw actuator configuredto selectively pivot the distal clamping jaw between a first positionfor delivery of the suture attachment assembly into the heart and asecond position for capturing a valve leaflet between the proximalclamping jaw and the distal clamping jaw; and a flexible memberextending from the jaw actuator through the catheter body to a distalsurface of the distal clamping jaw, wherein the jaw actuator selectivelymoves the flexible member to pivot the distal clamping jaw.
 2. Thesuture attachment catheter of claim 1, further comprising a control knobat the control handle, wherein the control knob is configured to controlboth the rail actuator and the jaw actuator.
 3. The suture attachmentcatheter of claim 2, wherein the control knob is configured to movedlongitudinally to control the rail actuator and to be rotated to controlthe jaw actuator.
 4. The suture attachment catheter of claim 1, whereinthe flexible member extends into a housing in the distal clamping jaw.5. The suture attachment catheter of claim 1, wherein the flexiblemember comprises a wire.
 6. The suture attachment catheter of claim 1,further comprising a wire loop extending from the proximal clamping jaw,the wire loop configured to effectively increase a capture area of theproximal clamping jaw.
 7. The suture attachment catheter of claim 6,wherein the wire loop is configured to automatically transition from acollapsed position to an expanded position when the proximal clampingjaw is extended out of a delivery catheter in the heart.
 8. The sutureattachment catheter of claim 1, wherein the distal clamping jaw includesa suture routing post configured to retain a suture thereon undertension.
 9. The suture attachment catheter of claim 1, wherein aperimeter of the distal clamping jaw defines a plurality of steppedteeth configured to enhance retention of the leaflet between the distalclamping jaw and the proximal clamping jaw.
 10. The suture attachmentcatheter of claim 9, wherein the proximal clamping jaw defines aplurality of stepped teeth configured to enhance retention of theleaflet between the distal clamping jaw and the proximal clamping jaw.11. The suture attachment catheter of claim 1, further comprising one ormore fiber optic cables extending from the control handle to theproximal clamping jaw, and wherein the proximal clamping jaw includes anopening on a clamping face of the proximal clamping jaw to enable theone or more fiber optic cables to confirm capture of a valve leafletbetween the proximal clamping jaw and the distal clamping jaw.
 12. Thesuture attachment catheter of claim 1, further comprising a needleselectively slideable within the catheter body, the needle configured tobe extended from the proximal clamping jaw to penetrate a valve leafletto insert a suture through the valve leaflet when the valve leaflet iscaptured between the proximal clamping jaw and the distal clamping jaw.13. The suture attachment catheter of claim 12, further comprising aneedle release disposed at the control handle, and wherein the needle isprevented from extending from the proximal clamping jaw until the needlerelease is actuated.
 14. The suture attachment catheter of claim 12,further comprising a suture configured to be retained on the distalclamping jaw for retrieval by the needle and a suture tensioningassembly disposed at the control handle, the suture tensioning assemblyconfigured to apply tension on the suture to enable the suture to beretained on the distal clamping jaw under tension.
 15. The sutureattachment catheter of claim 14, further comprising a suture release pindisposed in the handle, the suture release pin configured to release thetension on the suture to enable the suture to be retrieved from thedistal clamping jaw.
 16. The suture attachment catheter of claim 1,wherein the suture attachment assembly is less flexible than thecatheter body.
 17. The suture attachment catheter of claim 1, whereinthe suture attachment catheter is configured for insertion into a leftatrium of the patient's heart via a vascular access to a right atrium ofthe heart and a transseptal access between the right atrium and the leftatrium.
 18. The suture attachment catheter of claim 1, wherein the railis configured to slide in a channel of the proximal clamping jaw. 19.The suture attachment catheter of claim 18, further comprising a distalrail lock configured to prevent the rail from being slid distally beyondthe proximal clamping jaw.
 20. The suture attachment catheter of claim1, further comprising a proximal rail lock configured to prevent therail from being slid proximally to bring the distal clamping jaw closerthan a predetermined minimum distance from the proximal clamping jaw.